There were no new U.S. Veterinary Biologics Establishment Licenses or Permits (new permittees)

issued this quarter.

________________________________________________________________

New U.S. Veterinary Biologics Product Licenses and Biological Product Permits (new codes) were

issued as follows:

________________________________________________________________

There were no U.S. Veterinary Biologics Establishment Licenses or Permits (Permittees) terminated

this quarter.

________________________________________________________________

U.S. Veterinary Biological Product Licenses and Permits (codes) were terminated without prejudice

as follows:

United States Department of Agriculture

Animal and Plant

Health Inspection

Services

Veterinary Services

Center for Veterinary

Biologics

1920 Dayton Ave

PO Box 844

Ames, IA 50010

(515) 337-6100

CENTER FOR VETERINARY BIOLOGICS NOTICE NO. 22-09

TO:

FROM:

SUBJECT:

Biologics Licensees, Permittees, and Applicants

Directors, Center for Veterinary Biologics

Veterinary Services Leadership Team

David M. White

Acting Director

Issuance of Licenses

The purpose of this notice is to bring to the attention of interested parties licenses issued and

terminated between July 01, 2022 and September 30, 2022. These do not include those licenses

reissued to update pertinent information.

True Name Code Est. Name/No.

Canine Distemper-Adenovirus Type 2-Parvovirus Vaccine, Modified Live Virus 1331.27 Zoetis Inc./Est No. 190

Canine Parainfluenza-Bordetella Bronchiseptica Vaccine, Modified Live Virus,

Avirulent Live Culture

14M1.23 Intervet Inc./Est No. 165A

Lawsonia Intracellularis Bacterin 2799.20 Zoetis Inc./Est No. 190

True Name Code Est. Name/No.

Autogenous Bacterin B051.02 Hennessy Research Associates,

LLC/Est No. 597

Autogenous Bacterin B051.03 Hennessy Research Associates,

LLC/Est No. 597

Autogenous Vaccine, Killed Virus 1015.21 Hennessy Research Associates,

LLC/Est No. 597

Autogenous Vaccine, Killed Virus, Autogenous Bacterin D500.22 Hennessy Research Associates,

LLC/Est No. 597

Autogenous Virus, Killed Virus A015.20 Hennessy Research Associates,

LLC/Est No. 597

Avian Influenza Virus Antibody Test Kit, cELISA 5004.21 Zoetis Inc./Est No. 190

An Equal Opportunity Provider and Employer
CENTER FOR VETERINARY BIOLOGICS NOTICE NO. 22-09

Page 2

________________________________________________________________

There were no Product Licenses or Permits (codes) issued due to an acquisition this quarter.

True Name Code Est. Name/No.

Avian Influenza Virus Type A Antigen Test Kit E180.50 Zoetis Inc./Est No. 190D

Avian Influenza Virus Type A Antigen Test Kit 5180.50 Zoetis Inc./Est No. 190

Avian Leukosis Virus Antigen Test Kit 5007.00 Zoetis Inc./Est No. 190

Avibacterium Paragallinarum Bacterin 2658.00 Elanco US Inc./Est No. 196

Brucella Abortus Antibody Test Kit 5013.30 VMRD, Inc./Est No. 332

Bursal Disease-Marek's Disease Vaccine, Serotypes 2 & 3, Live Virus, Live

Marek's Disease Vector

1A88.R1 Boehringer Ingelheim Animal Health

USA Inc./Est No. 124

Canine Brucellosis Antibody Test Kit 5021.00 Zoetis Inc./Est No. 190

Canine Coronavirus Vaccine, Modified Live Virus 14P1.20 Boehringer Ingelheim Animal Health

USA Inc./Est No. 124

Canine Coronavirus-Parvovirus Vaccine, Modified Live Virus 14R1.20 Boehringer Ingelheim Animal Health

USA Inc./Est No. 124

Canine Distemper Vaccine, Live Canarypox Vector 1301.R0 Boehringer Ingelheim Animal Health

USA Inc./Est No. 124

Encephalomyelitis-Influenza-West Nile Virus Vaccine, Eastern & Western,

Killed Virus, Tetanus Toxoid

D6W5.22 Hennessy Research Associates,

LLC/Est No. 597

Encephalomyelitis-Rhinopneumonitis-Influenza Vaccine, Eastern & Western &

Venezuelan, Killed Virus, Tetanus Toxoid

D847.21 Hennessy Research Associates,

LLC/Est No. 597

Feline Interleukin-2 Immunomodulator, Live Canarypox Vector 9401.R0 Boehringer Ingelheim Animal Health

USA Inc./Est No. 124

Feline Leukemia Virus Antigen-Feline Immunodeficiency Virus Antibody Test

Kit

502A.00 Zoetis Inc./Est No. 190

Feline Rhinotracheitis-Calici-Chlamydia Psittaci Vaccine, Modified Live Virus,

Modified Live Chlamydia

16F1.21 Boehringer Ingelheim Animal Health

USA Inc./Est No. 124

Feline Rhinotracheitis-Calici-Panleukopenia-Chlamydia Psittaci-Rabies Vaccine,

Modified Live & Killed Virus, Modified Live Chlamydia

1619.20 Boehringer Ingelheim Animal Health

USA Inc./Est No. 124

Feline Rhinotracheitis-Calici-Panleukopenia-Rabies Vaccine, Modified Live &

Killed Virus

16T9.20 Boehringer Ingelheim Animal Health

USA Inc./Est No. 124

Feline Rhinotracheitis-Calicivirus Vaccine, Modified Live Virus 16C1.21 Boehringer Ingelheim Animal Health

USA Inc./Est No. 124

Mycoplasma Bovis Bacterin 2760.00 American Animal Health, Inc./Est No.

315

Staphylococcus Aureus Phage Lysate 9355.00 Delmont Laboratories, Inc./Est No. 339

Swine Influenza Virus Type A Antigen Test Kit 5181.50 Zoetis Inc./Est No. 190

An Equal Opportunity Provider and Employer